Keeping weight off after stopping GLP-1s using metformin with or without rapamycin or low‑dose naltrexone
Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation: A Randomized, Controlled Trial
This trial will test whether metformin alone or combined with low‑dose rapamycin or low‑dose naltrexone helps adults 40–85 maintain weight loss after they stop GLP‑1 medications.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | AgelessRx Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07092618 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled Phase 2/3 trial at a single AgelessRx site comparing four arms: control (no alternative medication), metformin, metformin plus rapamycin, and metformin plus low‑dose naltrexone. Eligible AgelessRx patients aged 40–85 with BMI ≥22 who have used GLP‑1s for at least three months and lost ≥15 lb will be randomized and followed during a six‑month period after gradual GLP‑1 cessation. The main outcome is percent weight regain over six months, with secondary outcomes including metabolic markers such as HbA1c and other safety measures. The trial uses repurposed, commonly available medications to test practical strategies for weight maintenance after stopping GLP‑1 therapy.
Who should consider this trial
Good fit: Ideal candidates are AgelessRx patients aged 40–85 with BMI ≥22 who have been on GLP‑1 therapy for at least three months and lost at least 15 pounds and who plan to discontinue GLP‑1s.
Not a fit: Patients with prior bariatric surgery, contraindications to metformin/rapamycin/naltrexone, recent use of other weight‑loss drugs, significant psychiatric illness, or who are pregnant/breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the regimen could offer a low‑cost, clinic‑based way to reduce weight regain and improve metabolic measures for people stopping GLP‑1 drugs.
How similar studies have performed: Metformin has some prior evidence for modest metabolic and weight effects, but using metformin combined with rapamycin or low‑dose naltrexone specifically to prevent weight regain after GLP‑1 cessation is largely novel and not established in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Existing AgelessRx patient * Adults (40 - 85 years of age) * Any sex * Any ethnicity * BMI ≥ 22 kg/m\^2 * Have been on GLP-1s (Wegovy, Ozempic, or a compounded form of GLP-1s) for at least three months before study initiation * Have lost at least 15 lbs during their GLP-1 use Exclusion Criteria: * Individuals who are denied a longevity product by the AgelessRx medical team will not be asked to participate in any product specific test(s) or questionnaire(s) * History of bariatric surgery * Use of weight-loss medications other than GLP-1s within the past 6 months * Age \<40 years * Contraindications to naltrexone, metformin, or rapamycin * Significant psychiatric illness that may affect participation * Pregnant or breastfeeding individuals
Where this trial is running
Chicago, Illinois
- AgelessRx — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Stefanie Morgan, PhD — AgelessRx
- Study coordinator: Sajad Zalzala, MD
- Email: doctor@agelessrx.com
- Phone: (313) 355-8657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.